Bayer to spend $20m to correct misleading advertising for oral contraceptive Yaz
Bayer Healthcare Pharmaceuticals has agreed to spend $20m (£14m; 15.6m) to correct misleading direct to consumer advertising of its birth control pill Yaz (drospirenone and ethinylestradiol), the most popular birth control pill in the United States, with sales of about $616m last year. The corrective advertisements began running last month and will continue through June, the US Food and Drug Administration (FDA) said.
Bayer reached an agreement with the FDA and 27 state attorneys general, led by Bill McCollum, the Florida attorney general. The agreement follows a warning letter sent to Bayer in October by Thomas Abrams, the director of the FDA’s division of drug marketing, advertising, and communications. It adds new requirements to a 2007 agreement about problems related to Bayer’s non-disclosure of safety risks associated with its marketing of Baycol (cerivastatin), which was withdrawn in 2001.
In the letter, Mr Abrams said two 60 second television advertisements for the drug “are misleading because they broaden the drug’s indication, overstate the efficacy of Yaz, and minimise serious risks associated with the use of the drug.
Mr Abrams said the advertisements promoted the use of the oral contraceptive for premenstrual syndrome, although it was indicated for treatment only of premenstrual dysphoric disorder, a more serious and less common problem, in women who choose an oral contraceptive as their method of birth control. Its efficacy for premenstrual dysphoric disorder had not been evaluated when used for more than three menstrual cycles. Similarly, the advertisements said that the drug helped keep the skin clear, although it was indicated for the treatment only of moderate acne vulgaris in women who wished to use an oral contraceptive.
BMJ 2009;338:b674